Deutschle, Gregor et al.Download PDFPatent Trials and Appeals BoardSep 4, 201914696078 - (D) (P.T.A.B. Sep. 4, 2019) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/696,078 04/24/2015 Gregor Deutschle 2133.274USU 5897 27623 7590 09/04/2019 OHLANDT, GREELEY, RUGGIERO & PERLE, LLP ONE LANDMARK SQUARE, 10TH FLOOR STAMFORD, CT 06901 EXAMINER KIPOUROS, HOLLY MICHAELA ART UNIT PAPER NUMBER 1799 MAIL DATE DELIVERY MODE 09/04/2019 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte GREGOR DEUTSCHLE, EDGAR PAWLOWSKI, JOERN WASSENBERG, ISABELL DUBRAU, and JUDITH AUERBACH ____________ Appeal 2019-000898 Application 14/696,078 Technology Center 1700 ____________ Before JEFFREY B. ROBERTSON, MICHAEL G. McMANUS, and MERRELL C. CASHION, JR., Administrative Patent Judges. ROBERTSON, Administrative Patent Judge. DECISION ON APPEAL1 STATEMENT OF THE CASE Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1–4, 6–13, and 21–28. (Appeal Br. 2.) We have jurisdiction pursuant to 35 U.S.C. § 6(b). We AFFIRM. 1 This Decision includes citations to the following documents: Specification filed April 24, 2015 (“Spec.”); Final Office Action mailed November 22, 2017 (“Final Act.”); Appeal Brief filed June 11, 2018 (“Appeal Br.”); Examiner’s Answer mailed September 18, 2018 (“Ans.”); and Reply Brief November 15, 2018 (“Reply Br.”). 2 Appellant/Applicant is Schott AG, which is also identified in the Appeal Brief as the real party in interest. (Appeal Br. 1.) Appeal 2019-000898 Application 14/696,078 2 THE INVENTION Appellant states the invention relates to a packaging unit for a pharmaceutical, medical, or cosmetic item, and use of the packaging unit for sterilizing and sterile transport of such items. (Spec. ¶ 2.) Claim 1 is representative and reproduced below from the Claims Appendix to the Appeal Brief: 1. A packaging unit for at least one pharmaceutical, medical, or cosmetic item, comprising: a sterilizing chamber for accommodating the item; and a prechamber that has a first gas-tight closure and a second gas- tight closure, the first gastight closure sealing, after receipt of the item in the sterilizing chamber through the prechamber, the prechamber from an exterior of the packaging unit, the second gas-tight closure sealing the prechamber from the sterilizing chamber by a gas-tight resealable closure, wherein the prechamber has a wall that has a portion comprising a wall material exhibiting selective permeability for sterilizing agents, the portion being between the first and second gas- tight closures to sterilize of an interior of the sterilizing chamber through the portion when the second gas-tight closure between the sterilizing chamber and the prechamber is unsealed and the first gastight closure between the prechamber and the exterior is sealed. (Appeal Br. (Claims Appendix) 9.) Claims 24 and 27 are also independent and recite similar packaging units with first and second gas-closures, and a gas permeable portion. (Id. at 11–12.) Appeal 2019-000898 Application 14/696,078 3 REJECTIONS 1. The Examiner rejected claims 1–4, 6–11, and 22–28 under 35 U.S.C. § 103 as obvious over Riese (US 4,637,061; issued January 13, 1987) and Yan (US 2005/0268573 A1, published December 8, 2005). 2. The Examiner rejected claims 12 and 13 under 35 U.S.C. § 103 as obvious over Riese, Yan, and Ludvig (US 2012/0205269 A1, published August 16, 2012) 3. The Examiner rejected claim 21 under 35 U.S.C. § 103 as obvious over Riese, Yan, and Haskin (US 6,649,236 B2; issued November 18, 2003). (Final Act. 4–15.) We select independent claims 1 and 27 for disposition of this appeal, which are representative of the subject matter claimed, and decide the appeal as to all grounds of rejection on the basis of the arguments presented for these claims (see Appeal Br. 4–8). 37 C.F.R. § 41.37(c)(1)(iv). Rejection 1 ISSUE The Examiner found, inter alia, Riese discloses a packaging unit having a lower chamber (sterilization chamber), an upper chamber (prechamber), first and second fasteners (closures), where Riese discloses a wall in the upper/prechamber of impermeable film. (Final Act. 4–5.) The Examiner found Riese discloses sterilizing the packaging unit. (Id. at 5.) The Examiner found Riese is silent as to the wall having a portion that exhibits selective permeability for sterilizing agents between first and second Appeal 2019-000898 Application 14/696,078 4 gas tight closures as recited in claim 1. (Id.) The Examiner found that Yan discloses a packaging unit for housing a medical item formed of a gas impermeable film, where a gas impermeable wall has a portion including a wall material exhibiting selective permeability to a gas sterilant such as ethylene oxide. (Id.at 5–6.) The Examiner found Yan discloses after sterilization of an item, an impermeable sealing patch is placed over the gas permeable portion to seal the packaging unit against subsequent gas permeation. (Id.) The Examiner determined it would have been obvious to modify Riese’s device to include a portion comprising a wall material exhibiting selective permeability as disclosed in Yan “to afford a user greater flexibility to sterilize the contents of the package after sealing of the package, while maintaining the package’s utility as an air-tight package by providing a sealing patch for sealing the permeable portion of the wall following sterilization.” (Id. at 6.) In addition, the Examiner determined it would have been obvious to have placed the permeable portion between the first and second gas-tight closures “as the skilled artisan would have recognized that such a placement would advantageously allow a user to sterilize an item located in the upper chamber of the packaging unit with sterilizing gas.” (Id.) Appellant makes the following arguments: (1) there is insufficient reasoning based on the evidence of record and absent hindsight to establish why one of ordinary skill in the art would have modified Riese to include Yan’s permeable portion between the first and second closures disclosed in Riese; (2) the modification of Riese proposed by the Examiner would render Riese unsuitable for its intended purpose of providing a leak and odor proof container for transport and storage; (3) the modification of Riese to include Appeal 2019-000898 Application 14/696,078 5 permeable portion and patch in Yan would lack the claimed permeability; and (4) Riese discloses a structure for protecting and preserving specimens, which teaches away from the proposed modification. (Appeal Br. 4–7.) Accordingly, the dispositive issue with respect to this rejection is: Has Appellant identified a reversible error in the Examiner’s determination that it would have been obvious to have incorporated the permeable wall portion disclosed in Yan into between the first and second closures in Riese’s device? DISCUSSION We are not persuaded by Appellant’s argument that the Examiner’s rationale is based on impermissible hindsight. Rather, we are of the view that the Examiner’s position is based sufficiently on the prior art as understood by one having ordinary skill. In this regard, the Examiner stated that the skilled artisan would have recognized that placing a permeable portion between the first and second fasteners (closures) of Riese’s pre- chamber (upper chamber) would allow a user to sterilize an item located in an upper chamber with sterilizing gas and would provide greater flexibility to a user by enhancing the utility of Riese’s device. (Ans. 5–6; see Riese Fig. 8, fasteners 23, 33; col. 3, ll. 20–46, col. 5, ll. 49–53.) Indeed, the broad disclosures in both Riese and Yan support the Examiner’s view that such flexibility would have been desired. Riese discloses that the container is sterilized before use with ethylene oxide gas, and Riese discloses further that the invention may be used “in connection with foods, microbiology, and other industrial applications.” (Riese, col. 5, ll. 19–30, col. 6, ll. 3–6.) Yan discloses a gas permeable layer or wall for Appeal 2019-000898 Application 14/696,078 6 sterilizing and packaging, which is “suitable for sterilization and packaging of other articles, including foods, pharmaceuticals, diagnostic and assay systems, sensitive electrical components, chemical system components, and the like, where the ability to sterilize articles after initial packaging has been completed is desirable.” (Yan, ¶¶32, 54.) As a result, we agree with the Examiner that one of ordinary skill in the art would have had reasons to have employed the gas permeable wall of Yan between the first and second fasteners in Riese to provide increased flexibility for sterilization of an item in the packaging unit of Riese. (Ans. 4–7.) See KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”); see also Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009) (“hold[ing] that while an analysis of obviousness always depends on evidence that supports the required Graham factual findings, it also may include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion.”) Thus, the Examiner’s rationale is supported sufficiently by the references of record as understood by the ordinary skilled artisan. Accordingly, we are not persuaded by Appellant’s argument that there is insufficient rationale absent hindsight to support the Examiner’s combination. We are not persuaded by Appellant’s argument that there would have been no reason to place Yan’s permeable portion between Riese’s first and Appeal 2019-000898 Application 14/696,078 7 second closures (fasteners 23 and 33) because Riese discloses a leak and odor proof container. As the Examiner points out, the proposed modification of Riese in view of Yan’s disclosure incorporates a sealing patch, which is capable of rendering the wall air-tight and leak proof. (Ans. 6.) In this regard, we agree with the Examiner that the Appellant’s argument that addition of the sealing patch would destroy the permeability recited in the claims is not commensurate in scope with the claims. (Ans. 6.) That is, the claims on appeal do not exclude a further treatment to cover the permeable wall portion. Indeed, claim 24 recites expressly the presence of a “sealing label” that “seals the wall material exhibiting selective permeability after the sterilizing agents sterilize of [sic] the interior of the sterilizing chamber.” Thus, Appellant’s argument is unpersuasive in view of the express language of the claims. We are not persuaded by Appellant’s argument that, because Riese discloses protecting specimens that are preserved in solution, Riese teaches away from the proposed modification “where sterilization is the opposite of protecting and preserving the specimen.” (Appeal Br. 6.) We agree with the Examiner that Appellant has not provided a sufficient explanation to conclude that the purposes of Riese and Yan are mutually exclusive. (Ans. 6–7.) As acknowledged by Appellant, sterilization of a specimen is not harmful. (Appeal Br. 6.) In addition, as the Examiner explains, Yan discloses that the packaging unit used for sterilization may serve as a sealed structure for protecting the item subsequent to sterilization. (Ans. 7, citing Yan ¶ 32.) The Examiner explains additionally that Riese discloses the item placed in the packaging unit is stored for future use, such that the advantage of sterilizing the item to make it more suitable for future use would be Appeal 2019-000898 Application 14/696,078 8 readily apparent to one of ordinary skill in the art. (Id. citing Riese, col. 1, ll. 12–18, col. 6, ll. 3–6.) Accordingly, Appellant’s arguments are not persuasive. Regarding claim 27, Appellant argues that the structure recited in the claim provides a simple structure that allows for insertion and sterilization of an item in a manner that cannot be predicted by those skilled in the art from Riese and Yan absent impermissible hindsight. (Appeal Br. 7–8.) We are not persuaded by this argument for essentially the same reasons discussed above with respect to claim 1. Accordingly, we sustain the Examiner’s rejection of claims 1–4, 6–11, and 22–28. Rejections 2 and 3 Appellant does not provide separate arguments with respect to dependent claims 12 and 13, the subject of Rejection 2, or dependent claim 21, the subject of Rejection 3. (See Appeal Br. 4.) Accordingly, we affirm Rejections 2 and 3 for similar reasons as discussed for Rejection 1. DECISION We affirm the Examiner’s decision rejecting claims 1–4, 6–13, and 21–28. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation